U.S. patent number 6,681,475 [Application Number 09/732,538] was granted by the patent office on 2004-01-27 for method of sealing a medical container with a plastic closure.
This patent grant is currently assigned to Becton Dickinson and Company. Invention is credited to Hubert Jansen, Volker Niermann, Jean-Claude Thibault.
United States Patent |
6,681,475 |
Thibault , et al. |
January 27, 2004 |
Method of sealing a medical container with a plastic closure
Abstract
A method of sealing a medical container such as a vial with a
polymeric closure, wherein the polymeric enclosure includes a
tubular collar portion and an integral radial portion, which
includes disposing the tubular collar portion over the radial rim
portion of the container to surround the reduced diameter neck
portion and radially deforming the tubular collar portion adjacent
its free end into the reduced diameter neck portion and against the
adjacent radial rim portion and, wherein the polymer selected for
the closure is sufficiently malleable to permit radial deformation,
yet sufficiently rigid to retain its shape following deformation
and sufficiently resistant to creep to maintain a seal between the
plastic closure and the container following radial deformation. In
the preferred embodiment of the method, the crimping tool or tools
include an inclined surface having a gradually decreasing angle of
inclination, which is driven against the tubular collar portion
adjacent the free end and the container and vial assembly and
crimping tool are relatively rotated. In the most preferred
embodiment of the method of this invention, the crimping tool
includes an inclined surface or surfaces, which may be separate
surfaces or a continuously inclined surface, to gradually and
progressively deform the tubular collar portion into the reduced
diameter neck portion and against the adjacent radial rim portion
in a cold forming process.
Inventors: |
Thibault; Jean-Claude (Saint
Egreve, FR), Jansen; Hubert (Jarrie, FR),
Niermann; Volker (Little Falls, NJ) |
Assignee: |
Becton Dickinson and Company
(Franklin Lakes, NJ)
|
Family
ID: |
24943916 |
Appl.
No.: |
09/732,538 |
Filed: |
December 8, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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168502 |
Oct 8, 1998 |
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Current U.S.
Class: |
29/511; 215/249;
53/410 |
Current CPC
Class: |
A61J
1/1406 (20130101); B65B 7/285 (20130101); B65D
51/002 (20130101); A61J 1/2096 (20130101); Y10T
29/49915 (20150115); Y10T 29/49918 (20150115); A61J
1/201 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); B65D 51/00 (20060101); B21D
039/00 () |
Field of
Search: |
;29/511,505,508,510,283.5 ;215/249,247,327,324
;604/411,403,405,414,126 ;53/410,416,420,422,483,486 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0098810 |
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Apr 1987 |
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EP |
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1 328 635 |
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Apr 1963 |
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FR |
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9504685 |
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Feb 1995 |
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WO |
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WO 97/39720 |
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Oct 1997 |
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WO |
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Primary Examiner: Vidovich; Gregory
Assistant Examiner: Kenny; Stephen
Attorney, Agent or Firm: Fortunato; David M.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This Application is a continuation-in-part of U.S. application Ser.
No. 09/168,502, filed Oct. 8, 1998, which claims priority under 35
U.S.C. Section 119(e) to U.S. Provisional Application Ser. No.
60/082,372, filed Apr. 20, 1998.
Claims
What is claimed is:
1. A method of sealing a container with a plastic closure, said
container having an open end, a radial rim portion surrounding said
open end, a reduced diameter neck portion adjacent said rim portion
and an enclosed container portion adjacent said neck portion, said
method comprising: forming a plastic closure of a polymer alloy
comprising a relatively malleable soft polymer and a relatively
rigid polymer, said plastic closure being sufficiently malleable to
permit radial deformation, yet sufficiently rigid to retain its
shape following deformation, and sufficiently resistant to creep to
maintain a seal between the container and the plastic closure
following radial deformation, said plastic closure including a
generally cylindrical tubular collar portion having an internal
diameter generally equal to or slightly greater than an outside
diameter of said rim portion of said container and an integral
radial rim portion; telescopically disposing said generally
cylindrical tubular collar portion of said plastic closure over
said rim portion of said container with said radial rim portion of
said plastic closure overlying said rim portion of said container
and said generally cylindrical tubular collar portion surrounding
said rim of said container having a free end surrounding said
reduced diameter neck portion of said container; radially deforming
said free end of said generally cylindrical tubular collar portion
of said plastic closure into said reduced diameter neck portion of
said container beneath said rim portion, said free end of said
plastic closure retaining its shape beneath said radial rim portion
of said container following deformation to permanently retain said
plastic closure on said container and sealing said container open
end; and deforming said free end of said tubular portion of said
plastic closure into said reduced diameter neck portion of said
container using a crimping tool having an inclined surface, said
method including relatively rotating said crimping tool and said
container with said plastic closure assembled thereon,
simultaneously driving said inclined surface against said tubular
portion of said closure adjacent said free end, simultaneously cold
forming said free end gradually into said reduced diameter neck
portion and against said rim portion of said container, permanently
deforming said free end into said reduced diameter neck portion and
against said rim portion of said container.
2. The method of sealing a container with a plastic closure as
defined in claim 1, wherein said container includes an elastomeric
stopper in said container open end having a radial portion
overlying said radial rim portion of said container, said method
including compressing said integral radial rim portion of said
plastic closure against said radial portion of said elastomeric
stopper to seal said plastic closure to said elastomeric stopper
and substantially simultaneously radially deforming said free end
of said closure tubular collar portion into said reduced diameter
neck portion of said container.
3. The method of sealing a container with a plastic closure as
defined in claim 1, wherein said inclined surface of said crimping
tool is frustoconical and said method includes rotating said
container with said plastic closure assembled thereon and rotating
said crimping tool.
4. The method of sealing a container with a plastic closure as
defined in claim 1, wherein said method includes sequentially
driving a plurality of crimping tools against said tubular portion
of said plastic closure adjacent said free end, each of said
crimping tools having an inclined surface of a decreasing angle of
inclination, thereby gradually deforming said plastic closure into
said reduced diameter neck portion without damaging said
closure.
5. The method of sealing a container with a plastic closure as
defined in claim 1, wherein said inclined surface of said crimping
tool is stationary having a gradually decreasing angle of
inclination and said method includes rotating said container with
said plastic closure assembled thereon and driving said container
with said plastic closure assembled thereon and driving said
container and plastic closure against said gradually decreasing
inclined surface.
6. The method of sealing a container with a plastic closure as
defined in claim 5, wherein said gradually decreasing inclined
surface is located on an inside surface of an arcuate rail and said
method including simultaneously rotating said container with said
plastic closure assembled thereon against said inclined tapered
surface of said rail, said tubular collar portion of said closure
adjacent said free end being deformed against said inclined
surface, and said tubular portion rolling along said arcuate inside
inclined surface of said rail, gradually cold forming the
circumference of said free end portion of said tubular collar
portion into said reduced diameter neck portion of said container
and against said radial rim portion.
7. The method of sealing a container with a plastic closure as
defined in claim 2, wherein said closure includes an integral
second tubular portion extending from said radial rim portion of
said closure generally coaxially aligned with said tubular collar
portion, said method including assembling a piercing element in
said second tubular portion releasably retained in said second
tubular portion and movable relative to said tubular portion,
telescopically disposing said tubular collar portion of said
closure on said rim portion of said container with said piercing
element telescopically coaxially aligned with said open end of said
container, then radially deforming said free end of said generally
cylindrical tubular collar portion of said closure into said neck
portion of said container.
8. The method of sealing a container with a plastic closure as
defined in claim 7, wherein said second tubular portion includes an
open end, said method further including sealing said open end of
said second tubular portion with a cap following radially deforming
said free end of said generally cylindrical tubular collar portion
of said closure into said neck portion of said container.
9. The method of sealing a container with a plastic closure as
defined in claim 1, wherein said method includes injection molding
said plastic closure.
10. A method of sealing a vial with a polymeric closure, said vial
having an open end, a radial rim portion surrounding said open end
and a reduced diameter neck portion adjacent said radial rim
portion, said method comprising: injection molding a polymeric
closure from a polymer which is sufficiently malleable to permit
radial deformation, yet sufficiently rigid to retain its shape
following deformation and sufficiently resistant to creep to
maintain a seal between the polymeric closure and the vial
following radial deformation, said closure including a generally
cylindrical tubular collar portion having an internal diameter
slightly greater than an outside diameter of said rim portion of
said vial and an integral radial rim portion; telescopically
receiving said tubular collar portion of said polymeric closure
over said radial rim portion of said vial with said rim portion of
said polymeric closure overlying said rim portion of said vial and
said tubular collar portion surrounding said rim portion and said
reduced diameter neck portion of said vial; and gradually cold
forming said tubular collar portion of said polymeric closure with
a crimping tool having an inclined surface facing said tubular
collar portion opposite said neck portion of said vial and
relatively rotating said vial and said crimping tool, said inclined
surface of said crimping tool gradually cold forming said tubular
collar portion of said polymeric closure radially inwardly into
said reduced diameter neck portion and against an adjacent surface
of said rim portion of said vial, permanently securing said closure
on said vial and sealing said open end.
11. The method of sealing a vial with a polymeric closure as
defined in claim 10, wherein said inclined surface of said tool is
frustoconical and said method includes relatively rotating said
crimping tool and said vial and relatively driving said
frustoconical surface against said tubular collar portion of said
polymeric closure adjacent a free end of said tubular collar
portion.
12. The method of sealing a vial with a polymeric closure as
defined in claim 11, wherein said method includes rotating said
vial with said polymeric closure assembled thereon relative to said
crimping tool and driving said tubular collar portion of said
polymeric closure against said inclined surface of said crimping
tool.
13. The method of sealing a vial with a polymeric closure as
defined in claim 11, wherein said method includes sequentially
driving a plurality of crimping tools against said tubular collar
portion, said crimping tools each having an inclined surface of a
decreasing angle of inclination, thereby gradually cold forming
said tubular collar portion of said polymeric closure radially
inwardly into said reduced diameter neck portion without damaging
said polymeric closure.
14. The method of sealing a vial with a polymeric closure as
defined in claim 11, wherein said inclined surface of said crimping
tool is located on an inside surface of an arcuate stationary rail
and said method includes driving said tubular collar portion of
said polymeric closure against said inclined surface and
simultaneously rotating said vial and said tubular collar portion
rolling along said arcuate inside tapered surface of said crimping
tool deforming the entire circumference of said tubular portion
against said rim portion of said vial.
15. The method of sealing a vial with a polymeric closure as
defined in claim 14, wherein said inclined surface of said crimping
tool has a gradually decreasing angle of inclination, wherein said
method includes driving said tubular collar portion of said
polymeric closure against said inclined surface having a gradually
decreasing angle of inclination, thereby gradually cold forming
said tubular collar portion of said polymeric closure radially
inwardly into said reduced diameter neck portion.
16. The method of sealing a vial with a plastic closure as defined
in claim 1, wherein said vial includes an elastomeric stopper in
said vial open end having a radial portion overlying said rim
portion of said vial, said method including compressing said
integral radial rim portion of said polymeric closure against said
radial portion of said stopper to seal said polymeric closure to
said stopper and substantially simultaneously radially deforming
said tubular collar portion of said closure into said reduced
diameter neck portion of said vial.
17. The method of sealing a vial with a polymeric closure as
defined in claim 16, wherein said polymeric closure includes an
integral second tubular portion extending from said radial rim
portion spaced from generally coaxially aligned with said tubular
portion, said method including assembling a piercing member in said
second tubular portion releasably retained in said second tubular
portion, telescopically disposing said tubular collar portion of
said closure on said rim portion of said vial with said piercing
member coaxially aligned with said open end of said vial and
movable relative to said elastomeric stopper to pierce said
stopper, then radially deforming said tubular collar portion of
said elastomeric closure into said neck portion of said vial.
18. The method of sealing a vial with a polymeric closure as
defined in claim 10, wherein said method includes injection molding
said polymeric closure from a polymer alloy comprising a relatively
malleable soft polymer and a relatively rigid polymer.
19. The method of sealing a vial with a polymeric closure as
defined in claim 18, wherein said method includes co-injecting a
polymer alloy including a polycarbonate and a soft malleable
co-polymer.
20. A method of sealing a container with a polymeric closure, said
container having an open end, a radial rim portion surrounding said
open end and a reduced diameter neck portion adjacent said rim
portion and an elastomeric septum received in said open end of said
container having a rim portion overlying said rim portion of said
container, said method comprising the following steps: forming a
polymeric closure including a generally cylindrical tubular portion
having an internal diameter slightly greater than an outside
diameter of said rim portion of said container and an integral
radial rim portion from a polymer which is sufficiently malleable
to permit radial deformation, yet sufficiently rigid to retain its
shape following deformation and sufficiently resistant to creep to
maintain a seal between said polymeric closure and said container
following radial deformation; telescopically receiving said tubular
collar portion of said polymeric closure over said radial rim
portion of said container and said rim portion of said elastomeric
septum with said rim portion of said polymeric closure overlying
said rim portion of said elastomeric stopper and said tubular
collar portion surrounding said rim portion and said reduced
diameter neck portion of said container; and simultaneously
compressing said rim portion of said polymeric closure against said
rim portion of said elastomeric septum and gradually cold forming
said tubular collar portion of said polymeric closure against an
inclined surface of a crimping tool having a decreasing angle of
inclination opposite said neck portion of said container and
relatively rotating said vial against said inclined surface of said
crimping tool, gradually cold forming said tubular collar portion
of said polymeric closure radially inwardly into said reduced
diameter neck portion of said container, permanently securing said
closure on said container and sealing said open end of said
container.
21. The method of sealing a container with a polymeric closure as
defined in claim 20, wherein said method includes sequentially
driving a plurality of crimping tools against said tubular collar
portion of said polymeric closure each having an inclined surface
of a different decreased angle of inclination, thereby gradually
cold forming said tubular collar portion of said polymeric closure
into said reduced diameter neck portion of said container.
22. The method of sealing a container with a polymeric closure as
defined in claim 20, wherein said method includes gradually cold
forming said tubular collar portion of said polymeric closure by
driving said container and polymeric closure against a stationary
crimping tool having a gradually decreasing angle of inclination
and simultaneously rotating said container and polymeric closure
while maintaining compression of said radial rim portion of said
polymeric closure against said rim portion of said elastomeric
septum.
23. A method of sealing a container with a plastic closure, said
container having an open end, a radial rim portion surrounding said
open end, a reduced diameter neck portion adjacent said rim portion
and an enclosed container portion adjacent said neck portion, said
method comprising: forming a plastic closure of a polymer which is
sufficiently malleable to permit radial deformation, yet
sufficiently rigid to retain its shape following deformation, and
sufficiently resistant to creep to maintain a seal between the
container and the plastic closure following radial deformation,
said plastic closure including a generally cylindrical tubular
collar portion having an internal diameter generally equal to or
slightly greater than an outside diameter of said rim portion of
said container and an integral radial rim portion; telescopically
disposing said generally cylindrical tubular collar portion of said
plastic closure over said rim portion of said container with said
radial rim portion of said plastic closure overlying said rim
portion of said container and said generally cylindrical tubular
collar portion surrounding said rim of said container having a free
end surrounding said reduced diameter neck portion of said
container; and, radially deforming said free end of said generally
cylindrical tubular collar portion of said plastic closure into
said reduced diameter neck portion of said container beneath said
rim portion, said free end of said plastic closure retaining its
shape beneath said radial rim portion of said container following
deformation to permanently retain said plastic closure on said
container and sealing said container open end, wherein said
deforming said free end of said tubular portion of said plastic
closure into said reduced diameter neck portion of said container
includes using a crimping tool having an inclined surface,
relatively rotating said crimping tool and said container with said
plastic closure assembled thereon, simultaneously driving said
inclined surface against said tubular portion of said closure
adjacent said free end, simultaneously cold forming said free end
gradually into said reduced diameter neck portion and against said
rim portion of said container, permanently deforming said free end
into said reduced diameter neck portion and against said rim
portion of said container.
24. The method of sealing a container with a plastic closure as
defined in claim 23, wherein said inclined surface of said crimping
tool is frustoconical and said method includes rotating said
container with said plastic closure assembled thereon and rotating
said crimping tool.
25. The method of sealing a container with a plastic closure as
defined in claim 23, wherein said method includes sequentially
driving a plurality of crimping tools against said tubular portion
of said plastic closure adjacent said free end, each of said
crimping tools having an inclined surface of a decreasing angle of
inclination, thereby gradually deforming said plastic closure into
said reduced diameter neck portion without damaging said
closure.
26. The method of sealing a container with a plastic closure as
defined in claim 23, wherein said inclined surface of said crimping
tool is stationary having a gradually decreasing angle of
inclination and said method includes rotating said container with
said plastic closure assembled thereon and driving said container
with said plastic closure assembled thereon and driving said
container and plastic closure against said gradually decreasing
inclined surface.
27. The method of sealing a container with a plastic closure as
defined in claim 26, wherein said gradually decreasing inclined
surface is located on an inside surface of an arcuate rail and said
method including simultaneously rotating said container with said
plastic closure assembled thereon against said inclined tapered
surface of said rail, said tubular collar portion of said closure
adjacent said free end being deformed against said inclined
surface, and said tubular portion rolling along said arcuate inside
inclined surface of said rail, gradually cold forming the
circumference of said free end portion of said tubular collar
portion into said reduced diameter neck portion of said container
and against said radial rim portion.
28. A method of sealing a container with a plastic closure, said
container having an open end, a radial rim portion surrounding said
open end, a reduced diameter neck portion adjacent said rim portion
and an enclosed container portion adjacent said neck portion, said
method comprising: forming a plastic closure of a polymer which is
sufficiently malleable to permit radial deformation, yet
sufficiently rigid to retain its shape following deformation, and
sufficiently resistant to creep to maintain a seal between the
container and the plastic closure following radial deformation,
said plastic closure including a generally cylindrical tubular
collar portion having an internal diameter generally equal to or
slightly greater than an outside diameter of said rim portion of
said container and an integral radial rim portion, an integral
second tubular portion extending from said radial rim portion of
said closure generally coaxially aligned with said tubular collar
portion, and an elastomeric stopper in said container open end
having a radial portion overlying said radial rim portion of said
container; assembling a piercing element in said second tubular
portion releasably retained in said second tubular portion and
movable relative to said tubular portion; telescopically disposing
said generally cylindrical tubular collar portion of said plastic
closure over said rim portion of said container with said radial
rim portion of said plastic closure overlying said rim portion of
said container, said generally cylindrical tubular collar portion
surrounding said rim of said container having a free end
surrounding said reduced diameter neck portion of said container,
and said piercing element telescopically coaxially aligned with
said open end of said container; compressing said integral radial
rim portion of said plastic closure against said radial portion of
said elastomeric stopper to seal said plastic closure to said
elastomeric stopper; and, radially deforming said free end of said
generally cylindrical tubular collar portion of said plastic
closure into said reduced diameter neck portion of said container
beneath said rim portion, said free end of said plastic closure
retaining its shape beneath said radial rim portion of said
container following deformation to permanently retain said plastic
closure on said container and sealing said container open end, said
compressing and said deforming being substantially
simultaneous.
29. The method of sealing a container with a plastic closure as
defined in claim 28, wherein said second tubular portion includes
an open end, said method further including sealing said open end of
said second tubular portion with a cap following radially deforming
said free end of said generally cylindrical tubular collar portion
of said closure into said neck portion of said container.
Description
FIELD OF THE INVENTION
This invention relates to an improved method of sealing a medical
container, such as a vial containing a medicament, drug or vaccine,
which eliminates the problems associated with malleable metal caps
or collars, such as aluminum. The method of this invention may be
used to seal a vial having an elastomeric stopper with a polymeric
closure or collar. The method of this invention may also be used
for sealing a vial or other medical container with a fluid transfer
set separate from or integral with the collar portion of the
closure.
BACKGROUND OF THE INVENTION
It is conventional to store medicaments, drugs or vaccines in a
sealed vial or other container for later use. Such medicaments,
drugs or vaccines may be in a dry or powdered form to increase the
shelf life of the drugs and reduce inventory space. Such dry or
powdered medicaments, drugs or vaccines are generally stored in a
sealed vial and reconstituted in liquid form for administration to
a patient by adding a diluent or solvent. Alternatively, the
medicament, drug or vaccine may be in liquid or even gaseous form.
A conventional vial for storing medicaments generally includes an
open end, a radial rim portion surrounding the open end and a
reduced diameter neck portion adjacent the rim portion. The vial is
conventionally sealed with an elastomeric stopper or septum which
generally includes a tubular portion inserted into the neck of the
vial and a planar radial rim portion which overlies the vial rim.
The stopper is normally secured to the vial with a thin malleable
metal cap, such as aluminum. The aluminum cap includes a tubular
portion which surrounds the rim portions of the stopper and vial,
an inwardly projecting annular portion which overlies the rim
portion of the stopper and a distal end portion which is crimped
radially into the vial neck beneath the vial rim portion. Because
aluminum is malleable, the collar accommodates the buildup of
tolerances of the dimensions of the stopper and vial rim. The
dimensions and tolerances of standard vials and stoppers are set by
the International Standards Organization (ISO).
The radial portion of the aluminum cap which overlies the stopper
rim portion may be closed, in which case the aluminum cap is
removed by "peeling" the aluminum cap from the vial. A pre-slit tab
located in the middle area may be provided which overlies the vial
rim, permitting the cap to be torn from the top and peeled from the
vial prior to use. This closed embodiment of an aluminum cap has
several disadvantages. First, the tearing of the metal cap creates
sharp edges which may cut or damage sterile gloves and cut the
person administering the drug, thereby exposing both the healthcare
worker and the patient to disease and contamination of the drug.
Second, the tearing of the aluminum cap generates metal particles
which may also contaminate the drug, medicament or vaccine. The
dangers associated with the tearing of an aluminum cap has been
solved in part by adding a "flip-off" plastic cap. In one such
embodiment, the aluminum collar includes a central opening and a
shallow plastic cup-shaped cap is received over the aluminum collar
having a central projecting riveting portion which is received and
secured in the central opening of the aluminum collar. The plastic
cap is then removed by forcing the flip-off cap away from the
aluminum collar, which tears an annular serrated portion
surrounding the central opening and exposes an opening in the
collar for receipt of a hypodermic needle or the like. This
embodiment reduces but does not eliminate the possibility of
tearing the sterile gloves of the healthcare worker. More
importantly, however, aluminum dust is still created which may
contaminate the medicament. It is also important to note that
metallic dust is also created simply by forming and affixing the
aluminum collar to the vial because aluminum dust is created in
forming the aluminum collar, crimping of the collar and removal of
the flip-off plastic cap.
Aluminum collars have also been used to secure a fluid transfer set
on medicament vials. Transfer sets may be utilized, for example, to
transfer fluid from a syringe to a vial, such as to reconstitute a
dry or powdered drug in a vial by adding a diluent or solvent. The
reconstituted drug may then be withdrawn from the vial by the
syringe. The inner surface of the transfer set may be part of the
drug fluid path and the aluminum collar or ring may bring aluminum
particles in the sterile room where the drug is added to the vial
or into the drug fluid path contaminating the drug. There have been
attempts to reduce this problem by applying a coating, such as a
polymeric coating, to the aluminum cap or collar. Finally, the
prior art also includes snap-on cup-shaped plastic caps or collars
having a radially inwardly projecting end portion which is snapped
over the rim portion of the vial. Snap-on plastic collars, however,
do not assure adequate sealing of the vial or fully accommodate the
tolerances of standard vials and stoppers as required.
The need therefore remains for a method of sealing vials and other
medical containers which may be utilized for sealing conventional
medical containers, such as medicament vials or cartridges, which
assures sealing of the container and which achieves a good level of
cleanliness, without metal particles or dust which will contaminate
the medicament, drug or vaccine, the transfer set or clean room and
which does not expose the health care worker to sharp edges. The
method of sealing a medical container of this invention eliminates
these problems and permits sealing of medical containers in an
aseptic environment.
SUMMARY OF THE INVENTION
As set forth above, the method of sealing a vial or other medical
container with a plastic closure of this invention eliminates the
problems associated with malleable metal or aluminum caps or
collars, but which accommodates build-up of tolerances of the rim
portion of the container and the elastomeric stopper, when used.
The plastic or polymeric closure of this invention is relatively
inexpensive to manufacture and use in the method of this invention.
The method of this invention may be utilized to seal a conventional
medical vial with a polymeric cap, a collar in combination with a
flip-off cap or with a collar used to secure and seal a transfer
set on a vial for transferring fluid between the vial and a second
container, such as a hypodermic syringe. As used herein, the term
"closure" is generic to either a cap or collar alone or in
combination with a transfer set.
As stated above, the method of sealing a container with a plastic
closure of this invention may be utilized with a conventional vial
or other medical container having an open end, a radial rim portion
surrounding the open end and a reduced diameter neck portion
adjacent the rim portion. The method of sealing a medical container
with a plastic closure of this invention includes forming a plastic
closure from a polymer, preferably formed by injection molding,
which is sufficiently malleable to permit radial deformation, yet
sufficiently rigid to retain its shape following deformation and
sufficiently resistant to creep to maintain a seal between the
plastic closure and the container following radial deformation. The
plastic closure formed by the method of this invention includes a
generally cylindrical tubular portion having an internal diameter
generally equal to or preferably slightly greater than an outside
diameter of the rim portion of the container and an integral radial
rim portion. In the preferred method of this invention, the plastic
closure is formed by injection molding a polymer alloy comprising a
relatively malleable soft polymer and a relatively rigid polymer.
The closure may be formed by co-injecting a polymer alloy which
preferably includes a polycarbonate as the relatively rigid
polymer.
The method of this invention then includes telescopically disposing
the tubular portion of the closure over the rim portion of the
container with the radial rim portion of the closure overlying the
rim portion of the container and the generally cylindrical tubular
portion surrounding the container rim having a free end surrounding
the reduced diameter neck portion of the container. The tubular
portion of the closure adjacent the free end is then deformed
radially inwardly into the neck portion of the container beneath
the rim portion and preferably against the rim portion adjacent the
neck portion, permanently securing the closure on the container and
sealing the container open end, wherein the free end of the plastic
closure retains its shape beneath the radial rim portion following
deformation and the polymer is sufficiently resistant to creep to
permanently maintain the seal. In the preferred method of sealing a
vial having medicament, drug or vaccine therein, the vial is
initially sealed with an elastomeric stopper having a tubular
portion received in the open end of the vial and a planar rim
portion which overlies the rim portion of the vial. The method of
this invention then preferably includes compressing the radial rim
portion of the plastic closure against the radial portion of the
stopper to seal the plastic closure to the stopper and
substantially simultaneously radially deforming the free end of the
closure tubular portion into the reduced diameter neck portion of
the vial as described above.
In the preferred method of sealing a container, such as a medical
vial, with a plastic or polymeric closure of this invention, the
cylindrical tubular portion of the closure is deformed radially
into the neck portion of the container using a crimping tool having
an inclined, chamfered or tapered surface and the vial or container
and the crimping tool are relatively rotated and driven together to
deform the tubular portion of the closure both radially into the
neck portion of the collar and axially against the adjacent rim
portion of the container to permanently secure the closure on the
container and seal the container. In one preferred embodiment of
the method of this invention, the crimping tool includes a
frustoconical chamfered surface which is rotated and driven against
the tubular portion of the closure, crimping the collar as
described. In this embodiment, the container or vial may be
simultaneously rotated to crimp and seal the entire periphery of
the rim portion. In another embodiment, the crimping tool includes
an arcuate or circular stationary rail having an inclined or
frustoconical chamfered surface and the method of crimping the
closure includes simultaneously driving the vial and closure
assembly against the rail and rotating the vial to crimp the
tubular portion of the closure radially inwardly into the reduced
diameter neck portion and axially against the adjacent rim portion
of the container as described. In either embodiment, the method is
preferably a cold forming process dependent upon the material of
the polymeric closure, which as described as above is sufficiently
malleable to permit radial deformation, yet sufficiently rigid to
retain its shape following deformation and sufficiently resistant
to creep to maintain the seal between the plastic closure and the
container following radial deformation.
In both preferred embodiments of cold forming the free end of the
plastic closure into the reduced diameter neck portion of the vial
or other container, the free end of the tubular collar portion is
preferably gradually or incrementally deformed radially into the
neck portion to assure permanent deformation, reduced creep and
reduce damage to the closure, such as stress cracking or
discoloration of a clear plastic closure. In the first embodiment
of the method of this invention described above, the free end of
the tubular closure is deformed incrementally by a series of
rotating crimping tools, wherein the first tool has a relatively
steep angle of inclination, such as 45 degrees. The angle of
inclination of the next crimping tool is then reduced, etc. to the
desired angle of the deformed lip, which may be, for example, 20 to
30 degrees. In the second embodiment of the method of this
invention described above, the angle of inclination of the crimping
surface of the rail is gradually reduced as the vial or other
container is rolled or rotated along the rail gradually cold
forming the free end of the closure and avoiding damage to the
closure including cracking and discoloration.
Where the method of sealing a vial or other medical container of
this invention is utilized to seal a transfer set on a vial or
other medical container, the closure may take the form of a collar
having a second tubular portion extending from the radial rim
portion of the collar, generally coaxially aligned with the tubular
collar portion received on the rim portion of the container. In the
method of sealing a transfer set on a vial or other medical
container, the components of the transfer set are assembled before
crimping of the collar on the medical container, preferably in an
aseptic or sterile environment. In the preferred embodiment, the
transfer set includes a piercing member which is telescopically
supported in the second tubular portion of the closure for piercing
an elastomeric stopper in the open end of the container or vial.
One important advantage of the method of sealing a vial or other
medical container of this invention is that the container may be a
conventional medical vial, as described above, having a
conventional elastomeric stopper. A conventional elastomeric
stopper has a tubular portion which is press fit into the open end
of the vial and a radial planar portion which overlies the rim
portion of the vial. The transfer set may also include a tubular
transfer member which telescopically receives the piercing member
and which may be integral with the second tubular portion of the
closure or separate from the collar portion and secured by the
collar portion. Finally, the preferred embodiment of the transfer
set also includes a cap which seals the open end of the second
tubular portion of the collar.
The method of sealing a transfer set on a vial or other medical
container with a plastic closure of this invention then includes
first assembling the transfer set, including telescopically
supporting the piercing member within the second tubular portion of
the closure. As described above, the closure includes a tubular
collar portion having an inside diameter generally equal to or
preferably slightly greater than the outside diameter of the radial
rim portion of the container or vial, a radial portion and a second
tubular portion which is coaxially aligned with the tubular collar
portion of the closure. The closure is then assembled on the vial
or other medical container by telescopically receiving the tubular
collar portion of the closure over the rim portion of the container
such that the tubular collar portion surrounds the rim portion of
the container and at least a portion of the reduced diameter neck
portion. The second tubular portion of the closure and the piercing
member are now coaxially aligned with the open end of the vial or
other medical container and moveable relative to the elastomeric
stopper to pierce the stopper. The method of this invention then
includes radially deforming the tubular collar portion of the
closure adjacent the free end into the reduced diameter neck
portion of the container and against the adjacent radial rim
portion, permanently securing the closure on the container and
sealing the container as described above. That is, the tubular
collar portion is preferably gradually or incrementally deformed or
cold formed as described above. In the most preferred embodiment of
the method of sealing a transfer set on a vial of this invention,
the radial portion of the closure is simultaneously compressed
against the radial planar rim portion of the elastomeric stopper as
the tubular collar portion is crimped in the neck portion of the
container and the piercing member is telescopically supported in
the second tubular portion of the closure for telescopic movement
to pierce the planar rim portion of the elastomeric stopper and
provide fluid communication between the vial or other medical
container and the tubular transfer portion of the transfer set. The
tubular transfer member may also include a Leur threaded connection
for receipt of a threaded Leur connection of a second container,
such as a syringe.
As set forth above, the method of sealing a container with a
plastic closure of this invention utilizes a polymer for the
closure having the requisite physical properties to provide and
maintain a seal between the plastic closure and the vial or other
medical container and permanently secure the closure on the
container. In the preferred embodiment, the plastic closure is
formed of a polymer alloy or melt blend which includes a relatively
tough soft malleable copolymer and a relatively rigid copolymer. In
the most preferred embodiment, the composite polymer is a polymeric
alloy of a relatively soft malleable copolymer and a relatively
rigid polymer. The preferred rigid polymer is a polyamid or a
polycarbonate and the preferred relatively soft copolymer may be
selected from polyesters or polyolefins. The resultant polymer
alloy or composite preferably has an elongation at yield between 5%
and 10% and an elongation at break greater than 100% with a
flectural modulus of greater than 1,900 MPa.
The method of this invention thus eliminates the problems and
hazards associated with the use of a malleable metal closure or
collar, such as aluminum, and plastic coated aluminum caps or
collars while assuring sealing of the container or damage to the
plastic closure. In the most preferred embodiment of the method of
this invention, the plastic closure or collar is formed by
injection molding the plastic closure from a polymeric alloy or
composite as described. A thermoplastic elastomer may also be
co-injected with the polymer forming the closure to form a coating
or film on the inside surface of the closure, which is integrally
bonded to the polymer of the closure. As used herein, the terms
"composite" and "alloy" are used in their broadest sense to include
alloys or melt blends, composites and copolymers.
Other advantages and meritorious features of the method of sealing
a vial or other medical container with a plastic closure or collar
of this invention will be more fully understood from the following
description of the preferred embodiments, the appended claims and
the drawings, a brief description of which follows.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side crosssectional side view of a plastic closure
secured to a conventional vial in sealed relation by the method of
this invention;
FIG. 2 is an exploded side crosssectional view of the components of
the assembly shown in FIG. 1 illustrating the method of assembling
the closure on the vial;
FIG. 3 is a partially crosssectioned side view of the assembly
shown in FIGS. 1 and 2 illustrating one embodiment of the method of
crimping the closure on the vial;
FIG. 4 is a crosssectional view of one embodiment of a vial and
transfer set assembly formed by the method of this invention;
FIG. 5 is a side crosssectional view of an alternative embodiment
of a transfer set and vial assembly formed by the method of this
invention;
FIG. 6 is a partial top perspective view of the transfer set
assembly shown in FIG. 5;
FIGS. 7 to 9 illustrate one method of crimping the transfer set
shown in FIGS. 5 and 6, wherein FIG. 7 is a perspective top
view;
FIG. 8 is a partially crosssectioned side view of FIG. 8 in the
direction of view arrows 8--8; and
FIG. 9 is an enlarged side partially cross sectioned view of FIG. 7
in the direction of view arrows 9--9;
FIGS. 10 to 13 illustrate an alternative method of sealing the
transfer set on a vial shown in FIGS. 5 and 6, wherein FIG. 10 is a
top perspective view and FIGS. 11 to 13 are a side partially cross
sectioned views in the direction of view arrows 11--11, 12--12 and
13--13.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
FIGS. 1 to 3 illustrate one preferred embodiment of the vial,
stopper and closure assembly 20 of this invention. As set forth
above, the method of this invention may be utilized to seal various
containers and is particularly useful for sealing medicament
containers such as the conventional vial 22 illustrated in FIGS. 1
to 3. The vial includes an open end 24, an annular radially
extending rim portion 26 and a reduced diameter neck portion 28
adjacent the rim portion. As shown, the neck portion 28 of the vial
has a reduced diameter when compared to the rim portion 26 and the
container portion 30 shown in FIG. 4. The internal surface 31 of
the vial adjacent the open end 24 is generally cylindrical. Medical
vials of this type are generally formed of glass or a sterilizable
plastic. The open end 24 of the vial is typically closed with an
elastomeric stopper 32 having a tubular body portion 34 which is
received in the open end 24 of the vial and a planar rim portion 36
which overlies the rim portion 26 of the vial as shown in FIG. 1.
The stopper is generally formed of a resilient elastomeric material
such as synthetic or natural rubber. The central portion 38 of the
planar rim portion 36 may be pierced with a hypodermic needle, for
example, to either withdraw fluid from the vial or add a solvent or
diluent to the vial where the medicament, drug or vaccine in the
vial is a dry or powder material. The tubular portion 34 of the
elastomeric stopper has an external diameter slightly greater than
the internal diameter of the internal cylindrical surface 31 of the
vial to provide a tight or interference fit.
One preferred embodiment of the closure 40 is shown in FIG. 1
attached to a vial 22 and stopper 32 assembly, prior to assembly in
FIG. 2 and during assembly in FIG. 3. This embodiment of the
closure 40 includes a tubular collar portion 42 which surrounds the
rim portion 26 of the vial and the planar rim portion 36 of the
stopper. Where the external surface of the rim portion 26 of the
vial is cylindrical, the tubular collar portion 42 of the closure
will generally also be cylindrical. As shown in FIG. 1 and
described below, the free end 44 of the tubular collar portion 42
is deformed inwardly or crimped into the reduced diameter neck
portion 28 and against the adjacent surface of the rim portion 26
of the vial, permanently securing the collar 40 on the vial and
sealing the vial. The preferred embodiment of the closure 40 also
includes an integral radial proximate portion 46 which overlies the
rim portions 26 and 36 of the vial and stopper, respectively. The
radial portion 46 is preferably integral with the tubular collar
portion 42 of the closure. This embodiment of the closure 40 also
includes a central opening 48 which overlies the central portion 38
of the stopper, preferably coaxially aligned with the central
portion of the stopper. As described below, however, the central
opening 48 may be eliminated in certain applications of this
invention. As used herein, the terms proximate and distal are used
solely for ease of description, wherein the term proximate refers
to elements or portions of elements closest to the rim portion 36
of the stopper and distal refers to elements or portions of
elements more remote from the rim portion of the stopper. Further,
the terms cap and collar are sometimes used herein interchangeably.
The term cap, however, generally refers to a closure having a
radial portion which overlies the container opening and collar is
sometimes used to refer to a closure used to secure an element,
such as a transfer set, to the container.
In this disclosed embodiment, the closure 40 includes a shallow
cup-shaped cap 50. In the disclosed embodiment, the cap 50 includes
a tubular portion 52 which surrounds the proximate portion of the
tubular portion 42 of the closure, an integral central radial
bridging portion 54 and a plurality of U-shaped tabs which, in the
disclosed embodiment, are integral with the central bridging
portion 54. The U-shaped tabs 56 are received through the central
opening 48 of the closure and snap in place to securely retain the
cap 50 on the closure 40. As shown in FIG. 2, the cap 50 is
preferably preassembled on the closure 40 prior to assembly of the
closure on the vial. The tabs 56 may also be separate members or
the central portion of the cap 50 including the tabs 56 may be a
separate member.
The closure 40 is then assembled on the vial 22 as shown in FIG. 2.
In a typical application, the tubular portion 34 of the stopper is
first inserted into the opening 24 of the vial 22, generally after
the vial is filled. As set forth above, the plastic closure 40 of
this invention may be used with various containers including
conventional medical vials as shown. Thus, in a typical
application, the vial 22 will first be filled with a medicament,
vaccine or drug. The tubular portion 42 of the closure 40 is then
received over the rim portion 36 of the stopper and the rim portion
26 of the vial as shown in FIG. 3 and describe below.
A method of crimping the collar or closure 40 on the vial 22 is
shown in FIG. 3. The free end 44 of the tubular collar portion 42
of the closure is crimped on the vial by a crimping tool 58 having
an inclined or tapered surface 60 which, in the disclosed
embodiment, is frustoconical. The crimping tool 58 is rotated in
one direction as shown by arrow 62 and in one embodiment, the
assembly of the closure 40 and vial 22 is rotated at the same speed
in the opposite direction as shown by arrow 64. The inclined
frustoconical surface 60 is driven against the tubular portion 42
of the closure as shown by arrow 68, which deforms the free end 44
radially inwardly against the reduced diameter neck portion 28 and
against the rounded edge 66 of the rim portion 26 adjacent the neck
portion 28. The radial portion 46 of the closure may be
simultaneously compressed against the planar radial rim portion 36
of the elastomeric stopper 32 to assure complete sealing of the
vial. In the preferred method of sealing a medical container with a
closure of this invention, the tubular portion 42 is crimped into
the reduced diameter neck portion 28 by cold forming. That is, the
crimping tool 58 is not heated to soften or partially melt the
polymeric closure as would be required with certain polymers. Thus,
as described below, the preferred polymer for the closure is
selected based upon its physical properties, as described above. In
the most preferred embodiment of the method of sealing a medical
container with a closure of this invention, the tubular portion 42
of the closure is gradually or incrementally deformed into the
reduced diameter neck portion 28 of the vial using a plurality of
crimping tools having different degrees of inclination or pitch or
the rim portion is deformed against a crimping tool having a
gradual change of pitch as described below with regard to FIGS. 7
to 9 and 10 to 13, respectively.
When the vial is ready for use, the cap 50 may be removed simply by
forcing one side of the cap 50 upwardly away from the closure 40,
removing the cap 50 from the closure 40 and exposing the central
opening 48 of the closure and the central portion 38 of the
stopper. The central portion 38 of the stopper may then be pierced
with a conventional hypodermic needle, for example, providing
access to the container portion 30 of the vial. Where the material
of the cap 50 is selected to provide resiliency, such as
polyethylene or polypropylene, the tabs 56 will bend under thumb
pressure, permitting easy removal of the closure 50. Alternatively,
where the material of the cap is relatively rigid, at least some of
the tabs 56 will break, also permitting removal of the cap. As
noted above, the radial portion 46 of the closure is preferably
compressed against the resilient rim portion 32 of the elastomeric
stopper during radial deformation of the free end 44 of the collar
portion to assure a secure seal of the vial following installation.
The tabs 56 are thus compressed into the radial rim 32 of the
stopper as shown in FIG. 1.
The polymer selected for the plastic closure and method of this
invention can best be described by its required physical
properties. The polymer must be sufficiently malleable to permit
radial deformation or crimping, yet sufficiently rigid to retain
its shape following deformation. The polymer must also be
sufficiently resistant to creep to maintain the seal between the
plastic collar portion and the container following radial
deformation. It has been found that a polymer having an elongation
at yield between 5% and 10% and an elongation at break greater than
100%, combined with a flexural modulus of greater than 1900 MPa has
superior performance. Where the plastic closure of this invention
is utilized for sealing vials containing a medicament, vaccine or
drug, the polymer should also be sterilizable and, in certain
applications such as the plastic closure for a vial transfer set
described below, the polymer is preferably relatively clear and
maintains its clarity under the stress of deformation or crimping.
It has been found that certain polymer alloys or composite polymers
including melt blends or alloys and co-polymers having polymers of
different malleability and rigidity are preferred in many
applications. That is, the plastic closure used in the method of
this invention is preferably formed of a polymer alloy, composite
polymer or co-polymer including a relatively rigid polymer and a
tough relatively soft malleable co-polymer. The most preferred
polymer is a polymer alloy or melt blend including a polyamid or
polycarbonate as the rigid polymer providing the strength and
resistance to creep desired for this application. The relatively
soft malleable co-polymer may be selected from various polymers
including polyesters and polyolefins; however, a polymer alloy
including a polycarbonate or polyamid and a polyester has been
found particularly suitable for this application.
As will be understood, various polymeric melt blends, alloys,
composites and co-polymers are being developed on a rapidly
increasing basis and therefore the plastic collar of this invention
is not limited to a specific polymer, provided the polymer has the
desired physical properties described above. Suitable polymers for
the plastic closures of this invention include EASTAR.RTM. MB
polymers, which are melt blend and alloy polymers and EASTAR.RTM.
thermoplastic polymers, which are neat polymers sold by Eastman
Chemical Company of Kingsport, Tenn. and Eastman Chemical AG of
Zug, Switzerland under the trade names "DA003, DN003" and "DN004".
These materials are polymeric melt blends, alloys and co-polymers
of polycarbonate or polyamid and polyester. As used herein, the
terms melt blends and alloys refer to polymeric compositions having
two or more polymers of different physical properties or
characteristics, such as the EASTAR.RTM. polymers of Eastman
Chemical Company described above which include a polycarbonate or
polyamid and a polyester. The polymer selected for the plastic
collar of this invention may also include fillers and other
constituents which would be more accurately described as a
composite, although the base polymers may still be a polymeric melt
blend or alloy. As used herein, the term alloy is used in its
broadest sense to include alloys or melt blends, composites and
co-polymers. As will be understood, the manufacturer or supplier of
the raw material will normally blend the polymers based upon the
specifications of the customer. The polymers may be co-injected to
form a polymeric melt blend, alloy or composite or formed by any
other suitable processes. It is anticipated, however, that other
polymers having the described physical characteristics may also be
utilized in the plastic collar or cap of this invention. In certain
applications, it may also be desirable to coat at least the
interior surface 43 of the collar shown in FIG. 2 with a
thermoplastic elastomer, or the entire collar may have a thin layer
of a thermoplastic elastomer. The thermoplastic elastomer coating
may be applied as a film or by co-injection with the polymer
forming the collar 40. The closure 40 and the cap 50 may be formed
by injection molding.
FIG. 4 illustrates one embodiment of a vial and transfer set
assembly, wherein the collar portion of the transfer set is secured
to the vial by the method of this invention. The transfer set 102
in FIG. 4 includes a tubular collar portion 104, an integral radial
portion 106 and a second tubular portion 108 which is integral with
the radial portion 106 and coaxially aligned with the tubular
collar portion 104 as shown. The preferred embodiment of the
transfer set 102 also includes a tubular transfer member 110 which,
in the disclosed embodiment, is integral with the second tubular
portion 108 by the radial bridging portion 112. The transfer set
further includes a piercing member 114 which is telescopically
received in the tubular transfer member 110 and includes a piercing
end 116 and a longitudinal channel 118 which provides communication
between the vial 22 and the tubular transfer member 110 as
described hereinbelow. The piercing member 114 is releasably
retained in the tubular transfer member 110 by a radial rim 120
extending from the internal surface 122 of the tubular transfer
member 110 and an annular groove 124 in the enlarged end portion
126 of the piercing member. The internal surface 128 of the tubular
transfer member adjacent the open distal end 130 may be slightly
tapered or conical to assist in the assembly of the piercing member
114 in the tubular transfer member 110 as described further below.
The proximate end of the tubular transfer member 110 preferably
includes a relatively sharp annular edge 132 to seal the
communication provided by the piercing member and the outer distal
surface may include Leur threads 134 to threadably receive a second
container such as a syringe, not shown, discussed further below. In
the disclosed embodiment, the radial portion 106 also includes an
annular projection having a sharp edge 136 providing an additional
seal for the transfer set and the disclosed embodiment includes
radially projecting ribs 138 bridging the tubular collar portion
104 and the radial portion 106 which prevent relative rotation of
the transfer set and the vial.
The elastomeric stopper 140 shown is also conventional in this
field. The elastomeric stopper includes a generally tubular portion
142 which is received in the open end 24 of the vial 22 with an
interference fit, wherein the outer diameter of the tubular portion
142 is slightly greater than the internal diameter of the open end
24 of the vial as described above. The stopper further includes a
reduced thickness portion 144, which is pierced by the piercing end
116 of the piercing member 114, as described below, and a planar
rim portion 146 which overlies the rim 26 of the vial. As shown in
FIG. 4, the second tubular portion 108 and the tubular transfer
member 110 are coaxially aligned with the open end 24 of the vial
following assembly and the piercing member 114 is generally
centrally located on the stopper 140 opposite the reduced thickness
portion 144. The disclosed embodiment of the transfer set 102
further includes a cap 148 having a central portion 150 bridging
the open end of the second tubular portion 108, a finger tab 152,
an arcuate portion 154 and a mid portion 156 which may be
adhesively bonded to the second tubular portion 108 as shown at
158. In a disclosed embodiment, the distal end of the second
tubular portion 108 includes a radial flange 160 which receives the
central portion 148 of the cap which may be adhesively bonded to
the radial flange portion 160. As described above in regard to FIG.
3 and below in regard to FIGS. 7 to 11, the tubular collar portion
104 adjacent the free end 162 is deformed radially inwardly into
the reduced diameter neck portion 28 and against the adjacent
surface of the radial rim portion 26, permanently retaining the
tubular collar portion 104 and the transfer set 102 on the vial as
shown in FIG. 4.
The assembly and use of the transfer set 102 and vial assembly may
now be briefly described, as follows. First, the piercing member
114 is assembled in the tubular transfer member 110, wherein the
interlocking rim 120 and groove 124 releasably retains the tubular
transfer member in the position shown. The cap 148 may be
preassembled on the second tubular portion 108 by adhesive bonding
as described, but is preferably added after assembly, at the
transfer set on the vial. The transfer set is then assembled on the
vial by telescopically receiving the tubular collar portion 104 on
the rim portion 26 of the vial, wherein the free end 162a (shown in
phantom) is received around the reduced diameter neck portion 28 as
shown. The free end 162 of the tubular collar portion is then
deformed into the reduced diameter neck portion 28 as described
above or as described below in regard to FIGS. 7 to 11. The vial
and transfer set assembly is now ready for use.
As set forth above, the vial 22 may contain, for example, a dry or
powdered substance, such as medicaments, drugs or vaccines, and
wherein the dry substance may be reconstituted in liquid form for
administration to a patient by adding a diluent or solvent. In this
application, the cap 148 is removed by pulling the pull tab 152
which first breaks the adhesive bond 158 and then the adhesive bond
of the central portion 150 on the radial flange exposing the
tubular transfer member 110 and the piercing member 114. Where the
dry substance is to be reconstituted with liquid from a syringe,
for example, the barrel portion of the syringe (not shown) is
threaded onto the Leur connector threads 130, which drives the tip
portion of the syringe against the piercing member 114. The
piercing member is then driven through the reduced thickness
portion 144 of the elastomeric stopper providing fluid
communication between the syringe and the vial 22. Where the vial
contains a powdered substance as described, fluid from the syringe
may then be forced through the longitudinal channel 118 of the
piercing member into the vial, the powdered substance reconstituted
and withdrawn by the syringe, as is well known in this art.
FIGS. 5 and 6 illustrate an alternative embodiment of a transfer
set 202 which includes an improved cap 248 as described below.
Otherwise, the transfer set 202 may be identical to the transfer
set 102 described above in regard to FIG. 4 and the components of
the transfer set, vial 22 and elastomeric stopper 140 are numbered
in the same sequence, except that the components are numbered in
the 200 series in FIG. 5. Therefore, no further description of
these components is required, except as set forth below.
In the embodiment of the cap 248 shown in FIGS. 5 and 6, the
central portion 250 bridges the open distal end of the second
tubular portion 208 as shown in FIG. 5. The cap further includes an
integral outer tubular portion 252 and a concentric inner tubular
portion 254 which, in a disclosed embodiment, are cylindrical to
receive the distal end of the cylindrical tubular portion 208 as
shown in FIG. 5. The outer tubular portion 252 is integrally joined
to the central portion 250 by a plurality of spaced frangible
portions 256 as best shown in FIG. 7. An integral rim 258 is
provided on the exterior surface of the second tubular portion 208
adjacent the distal end and opposite the frangible portions 256
includes a radial rib 258 which facilitates breaking of the
frangible portions 256 as described below. In the disclosed
embodiment, the interior surface of the inner tubular portion 254
includes a plurality of annual ribs 260 which seals against the
interior surface of the second tubular portion 208. Further, the
central portion 250 includes a radial rib 262 which permits
gripping of the central portion to remove the cap, as now
described. When the transfer set 202 is assembled on the vial 22 as
described below in regard to FIGS. 7 to 11, the cap is removed by
pressing the flange 262 away from the transfer set, which breaks
the frangible portions 256, permitting removal of the cap. The cap
may be formed of any suitable plastic, include polyethylene and
polypropylene or relatively harder polymeric materials.
FIGS. 7 to 13 illustrate alternative methods of crimping the collar
or closure on a conventional vial, wherein the embodiment of the
transfer set illustrated is as shown in FIGS. 5 and 6 and the
collar is gradually or incrementally deformed into the neck portion
of the vial by cold forming. The embodiment of the crimping
apparatus and method illustrated in FIGS. 7 to 9 may be utilized to
seal vials or other containers with a plastic or elastomeric
closure up to about 200 vials per minute. The crimping apparatus
and method disclosed in FIGS. 10 and 11 may be used for higher
volume applications, wherein the through put may be as great as 600
vials per minute.
In the embodiment of the crimping or capping apparatus disclosed in
FIGS. 7 to 9, the crimping apparatus 300 includes a plurality of
crimping tools, wherein the inclined surfaces of the crimping tools
have differing degrees of pitch incrementally deforming the free
end 162 of the tubular collar portion as now described. The
embodiment of the crimping apparatus 300 shown in FIG. 7 includes
four rotatable crimping tools 302 to 308, each having a shaft 310
to 316, respectively, and an inclined or tapered surface 318 to
324, respectively, on the roller portion of the crimping tool 326
to 332, respectively. The pitch or angle of inclination of the
inclined surfaces 318 to 324 decreases progressively as the vial
progresses through the stations of the crimping apparatus. That is,
the pitch of the inclined surface 320 of crimping tool 304 of the
second station is less than the pitch of the inclined surface 318
of the crimping tool 302 of the first station, etc.
FIG. 8 illustrates the first station of the crimping apparatus 300.
The vial and transfer set assembly is supported on a support member
334, which is preferably resiliently biased to compress the radial
portion 206 against the rim portion 146 of the elastomeric stopper
140 during crimping as set forth above. In the disclosed
embodiment, the vial 22 is supported on a support member 334, which
is supported on a base 336 by piston 340 and is spring biased by a
suitable resilient member, such as spring 338. The upper end of the
second tubular portion 308 is supported by a cup-shaped support
member 342 which is affixed to a rotatable shaft 344. The
cup-shaped support member 342 may also be spring biased downwardly
as shown by arrow 346. The assembly is then rotated against the
rotatable crimping tool 302 in the first station, which includes a
rotatable shaft 310 having a roller portion 326. As set forth
above, the roller portion 326 includes an inclined or tapered
surface 318 which deforms the free end 262 of the tubular collar
portion 204 radially inwardly into the reduced diameter neck
portion 28 of the vial 22. The relative rotation of the crimping
tool 302 and the vial and transfer set assembly is shown by arrows
348 and 350, wherein the crimping tool and vial and transfer set
assembly are rotated in opposite directions. As will be understood,
however, one of the crimping tool and vial and transfer set
assembly may be the drive member and the other may be the driven
member wherein only the drive member is rotated and the other
member follows. The base 336 is supported in the disclosed
embodiment on a turntable 352, as shown in FIG. 7, such that the
vial and transfer set assembly is moved from station to station. In
the first station, as shown in FIG. 8, the inclined surface 318 has
a relatively steep angle, which deforms the free end 262 only
partially into the reduced diameter neck portion 28 as shown at the
right side of FIG. 8. As set forth above, the inclined surface of
the crimping tool at each station is reduced, such that the
crimping tool in the final station deforms the free end 262 of the
tubular collar portion 204 into and against the reduced diameter
neck portion and against the adjacent surface of the rim portion 26
of the vial as shown in FIG. 9. The crimping apparatus 300 thus
performs the method of this invention as described above.
FIGS. 10 to 13 illustrate an alternative crimping apparatus 400,
wherein the crimping tool includes a circular rail 402 supported on
a suitable support 404. The rail 402 includes an inclined surface
406 which gradually changes in pitch from the inlet 408 to the
outlet 410. That is, the tubular collar portion 204 is driven
against the tapered surface 406 at the inlet 408 and the pitch of
the tapered surface is continuously decreased along the rail to the
outlet 410, wherein the free end portion 406 of the tubular collar
portion is deformed as shown at the right in FIG. 11. The vial and
transfer set assembly is continuously rotated as the tubular collar
portion is driven against the rail as shown by arrows 412 and 414.
FIG. 11, which is a partial cross sectional view through view
arrows 11--11, illustrates the initial deformation of the tubular
collar portion 204 adjacent the entrance 408, wherein the angle of
inclination of the chamfered or frustoconical surface 406 is
relatively steep, such as about 40 to 50 degrees or greater. FIG.
12, which is a partial cross sectional view through view arrows
12--12, illustrates the angle of inclination of the chamfered
surface 406 of the rail 404 about midway through the cold
deformation of the tubular collar portion, wherein the angle of
inclination is less than 40 degrees. Finally, FIG. 13 illustrates
the angle of inclination 406 of the chamfered surface adjacent the
outlet 410, wherein the angle of inclination is less than 30
degrees, fully deforming the free end of the tubular collar portion
204 into the reduced diameter neck portion 28 of the vial and
against the rim portion 26. Thus, the rim portion is gradually
deformed by the continuously decreasing angle of inclination of the
chamfered or frustoconical surface 406 in a gradual and continuous
process. FIG. 13 also illustrates the simultaneous compression of
the radial portion 206 of the collar against the planar portion 146
of the elastomeric closure and compression of the closure against
the rim portion 26 of the vial during cold forming of the tubular
collar portion 204 as described above in regard to FIG. 8, which is
a preferred embodiment of the method of this invention.
Thus, in both of the preferred embodiments of cold forming the free
end of the plastic closure into the reduced diameter neck portion
of the vial or other medical container as described above and shown
in FIGS. 8 and 9 and FIGS. 10 to 13, respectively, the free end is
gradually or incrementally deformed radially into the neck portion
to assure permanent deformation, reduce creep which could result in
leakage and reduce damage to the closure, such as cracking or
discoloration of a clear plastic closure. Thus, the method of this
invention provides a simple and relatively inexpensive method of
crimping or cold forming a plastic closure or collar which avoids
the disadvantages of a malleable metal closure or collar and which
assures complete sealing of the vial. The tubular collar portion of
the closure or collar may also be deformed into the reduced
diameter neck portion of the vial or other container by a crimping
device (not shown) having a jaw which deforms the free end portion
of the tubular collar portion into the neck portion one at a time
provided the deformation is gradual to avoid damage to the collar
portion.
The deformation of the free end of the collar portion in each of
these embodiments is a cold forming process which, as set forth
above, also relies upon the polymer selected for the collar or
closure. That is, the polymer selected must be sufficiently
malleable to permit radial deformation or crimping without forming
stress cracking or fractures. Further, the polymer must be
sufficiently rigid to retain its shape following deformation.
Finally, the polymer must also be sufficiently resistant to creep
to maintain the seal between the plastic closure or collar and the
container following radial deformation to prevent leakage or
contamination of the materials stored in the container. One
important advantage of the method of this invention is that the
crimping process may be performed in an aseptic environment
preventing contamination of the material within the vial and the
assembly. As set forth above, another important advantage of the
method of this invention is that the improved polymeric closure
eliminates the potential contamination and hazards associated with
malleable metal closures, such as aluminum. As will be understood,
various modifications to the disclosed methods of sealing a vial or
other container with a polymeric closure of this invention within
the purview of the appended claims.
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